NCT03691064进行中（未招募）不适用
International, Non-interventional, Post-Authorization Long-Term Safety Study of Lutathera, in Patients With Unresectable or Metastatic, Well-Differentiated, Somatostatin Receptor Positive, Gastroenteropancreatic Neuroendocrine Tumours
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,014
- 试验地点
- 5
- 主要终点
- secondary cancers: incidence of secondary cancers
研究概览
简要总结
Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).
详细描述
To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (fulfilling the definition of "age of majority" per local regulations),
- •with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs
- •and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending).
排除标准
- •Hypersensitivity to Lutathera (active substance or any of the excipients),
- •presence of established or suspected pregnancy or pregnancy not excluded,
- •presence of kidney failure with creatinine clearance < 30 mL/min.
研究组 & 干预措施
LUTATHERA
Treated per labeled LUTATHERA dosing regimen.
干预措施: LUTATHERA (Drug)
结局指标
主要结局
secondary cancers: incidence of secondary cancers
时间窗: up to 7 years follow-up
incidence of secondary cancers
次要结局
- safety profile: incidence of adverse events(up to 7 years follow-up)
- mortality(up to 7 years follow-up)
- LUTATHERA number of administrations(completion of treatment phase (approximately 2 years total))
- LUTATHERA dose per administration(completion of treatment phase (approximately 2 years total))
- LUTATHERA total dose(completion of treatment phase (approximately 2 years total))
研究者
研究点 (5)
Loading locations...
相似试验
已完成
2 期
An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1PH1Primary HyperoxaluriaRNAi TherapeuticsiRNAAGTNCT03350451Alnylam Pharmaceuticals20
已完成
不适用
Juvenile Idiopathic Arthritis (JIA) RegistryJIAJuvenile Idiopathic ArthritisNCT00783510AbbVie849
进行中（未招募）
3 期
A Long-term Follow-up Study of Sotatercept for PAH Treatment (MK-7962-004/A011-12)Pulmonary Arterial HypertensionPAHNCT04796337Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA815
招募中
1 期
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical TrialKnee OsteoarthritisNCT04339504Medipost Co Ltd.12
已完成
不适用
5 Year Observation of Patients With PORTICO ValvesAortic Valve StenosisNCT01802788Abbott Medical Devices1,032